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Piracetam not banned; but it's going to be difficult to sell


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#1 Grapevine

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Posted 20 September 2010 - 06:45 PM


(EDIT- Apparently I'm incapable of paying attention to topic title character limits. Apologies, and also, :facepalm:.)

If you are not familiar with the background surrounding this debate, I suggest you read the thread FDA says no more piracetam.

I got a reply from my FDA lawyer contact this morning, and she has explained the issue further. Her reply:

This is really interesting. I can give you my thoughts after reading through the materials, though obviously with a caveat (and people wonder why lawyers are so hated!) -- I have not been retained by you or any other party as legal counsel in regard to this matter, therefore the following is merely my opinion and in no way constitutes legal advice, and should not be relied upon as such.

That taken care of, here is my general impression, although without all of the details about the company and its history, it's hard to fully evaluate the situation. Yes, this is a standard FDA Warning Letter, and yes, the owner of Smartpowders appears to be mistaken in taking the 15 day time frame as an effective date for a ban. However, that's not to say that anyone selling piracetam should carry on as usual.

Here's the deal -- there is no such thing as an "unregulated" product that is intended for human or animal ingestion. It is either a drug or it's a food (dietary supplements fall under the umbrella of foods). Normally in a Warning Letter, the issue is that the manufacturer is making claims about what the product can do that go beyond the scope of dietary supplements, thereby rendering the product an unapproved new drug. What FDA says in the letter above (it is now posted in full on FDA's website), and what is unusual about this situation, is that FDA has determined that piracetam is excluded from the definition of a dietary supplement. It is not eligible for sale under the food umbrella, therefore the only avenue that remains is that of a drug. Piracetam has not been "banned" per se, but it is not eligible for sale as a supplement. It would have to be approved as a drug in order to continue to be sold, and that is likely cost prohibitive for most manufacturers, as the application filing fee alone is over $1M.

This is not a new issue for Smartpowders. According to a footnote in the Warning Letter, it appears that Smartpowders filed a New Dietary Ingredient notification with FDA in 2004, informing the agency that it intended to sell piracetam as a dietary supplement. FDA informed Smartpowders at that time that piracetam did not fall within the definition of a dietary supplement, but the company went ahead with the product. They were pretty lucky to fly under the radar for as long as they did, but the new administration at FDA has really stepped up their enforcement of supplements, so it is not surprising that they were discovered.

As for the 15 day window, FDA did not state that the product would be banned after that time. Rather, they requested that the company submit a corrective action plan addressing each violation listed in the Warning Letter and that the plan be filed within 15 days -- standard procedure. However, because of the way FDA described the piracetam violation, it is highly unlikely that the company would be able to respond adequately other than to say it was removing the product from the market. Not a ban, but the product will not be eligible for sale unless it is approved as a drug, or unless the company successfully challenges FDA's classification of piracetam as beyond the scope of supplements.


So, piracetam doesn't fall under the definition of a dietary supplement. We knew this. However, given the new information here, I would assume this would extend to more nootropics than just piracetam, given part of the letter Mike received:

The issues and violations cited in this letter are not intended to be an all-inclusive statement of the violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.



I maintain that Mike was wrong to send out multiple emails and start threads across a variety of forums creating a lot of hype about how piracetam was "banned." He did a very poor job of explaining the situation and led people to believe things that were not true. Whether he is doing this intentionally or because he lacks the ability to fully understand the situation, I don't know. I now have a clearer understanding of why he is unable to sell it, hopefully this helps everyone else get a better idea of what's going on.

Edited by Grapevine, 20 September 2010 - 06:49 PM.

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#2 chrono

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Posted 20 September 2010 - 10:25 PM

Here's the deal -- there is no such thing as an "unregulated" product that is intended for human or animal ingestion. It is either a drug or it's a food (dietary supplements fall under the umbrella of foods).

In asking before about how much the claims issue contributed to this injunction, I was wondering whether piracetam could be sold "not for human consumption" without violating the relevant acts.

Edited by chrono, 21 September 2010 - 12:14 AM.
grammar police


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#3 Mike M

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Posted 20 September 2010 - 11:06 PM

but the product will not be eligible for sale unless it is approved as a drug, or unless the company successfully challenges FDA's classification of piracetam as beyond the scope of supplements.


FDA has determined that piracetam is excluded from the definition of a dietary supplement. It is not eligible for sale under the food umbrella, therefore the only avenue that remains is that of a drug.


I've stated NUMEROUS times that the FDA has always considered this a drug and not legal. To them, it is NOT legal to sell. What word would you like to call it? If something is banned, it means I can't sell it. I can't sell pro hormones because the FDA considers them a drug. They were banned from being sold. This action by the FDA was the first legit move towards enforcing their stance that Piracetam is a DRUG, therefor illegal to sell, therefor banned.

I grasp this situation fully. While many on the outside have commented on what they THINK the FDA believes, I'm the ONLY person on this board that actually talked to them. Even though I openly posted Mr. Price's contact information for people. I have no desire to get into a big fight with the FDA over piracetam. Other vendors have already been visited/notified since my visit, per the other posts on this board. I'm not sure how this could be made any simpler. Your own lawyer just told you it was a drug. You can't sell drugs OTC. I can't import them for sale legally. If that's not "banned" by your definition, I'm not sure what is.

You say it's going to be "difficult" to sell. What part of your lawyer's response makes you think it's legal (please quote her words) to sell as a dietary supplement?
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#4 chrono

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Posted 20 September 2010 - 11:21 PM

If something is banned, it means I can't sell it.

Indeed, but just because you're not allowed to sell something as a dietary supplement doesn't make it "banned," really. At least not in the blanket way you've implied since the beginning of this.

Other vendors have already been visited/notified since my visit, per the other posts on this board.

Link to this? The only other thread I see is the one wherein RI mentions that "other businesses" have been notified, which no doubt refers to the warning letter to you.

#5 Grapevine

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Posted 20 September 2010 - 11:30 PM

but the product will not be eligible for sale unless it is approved as a drug, or unless the company successfully challenges FDA's classification of piracetam as beyond the scope of supplements.


FDA has determined that piracetam is excluded from the definition of a dietary supplement. It is not eligible for sale under the food umbrella, therefore the only avenue that remains is that of a drug.


I've stated NUMEROUS times that the FDA has always considered this a drug and not legal. To them, it is NOT legal to sell. What word would you like to call it? If something is banned, it means I can't sell it. I can't sell pro hormones because the FDA considers them a drug. They were banned from being sold. This action by the FDA was the first legit move towards enforcing their stance that Piracetam is a DRUG, therefor illegal to sell, therefor banned.

I grasp this situation fully. While many on the outside have commented on what they THINK the FDA believes, I'm the ONLY person on this board that actually talked to them. Even though I openly posted Mr. Price's contact information for people. I have no desire to get into a big fight with the FDA over piracetam. Other vendors have already been visited/notified since my visit, per the other posts on this board. I'm not sure how this could be made any simpler. Your own lawyer just told you it was a drug. You can't sell drugs OTC. I can't import them for sale legally. If that's not "banned" by your definition, I'm not sure what is.

You say it's going to be "difficult" to sell. What part of your lawyer's response makes you think it's legal (please quote her words) to sell as a dietary supplement?



Not MY lawyer, an FDA lawyer who frequently deals with labeling issues that I recently met in a situation completely unrelated to my interest in any of this piracetam crap. So, no, Mike, you're not the only one that's talked to the FDA anymore. I'm not going to argue with you about semantics, because I have spent far too much time trying to explain to you why your use of "banned" is misleading, and am not going to waste any more on this. You seem to miss the point of all of my posts (show me where I said it was legal to sell as a dietary supplement-- rereading my own post, I see that I said the very opposite).

Your understanding of the word "drug" also seems to be flawed-- you can't sell them OTC, you say? What's acetaminophen (Tylenol) then? A dietary supplement? Like I said, semantics. This is why I have a massive issue with your posts. I'm not saying it's all well and good for you to keep selling piracetam. I never have. While there was a point at which I thought it was more a labeling problem than anything else, I have done my research and found that I was mistaken. My issue is the manner in which you go about discussing the matter.

This post is already too long and I refuse to keep going in circles about this.


Chrono, that's an interesting point that you bring up, and one I was wondering myself. Let me see if I can get any more info on that.
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#6 Grapevine

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Posted 20 September 2010 - 11:35 PM

If something is banned, it means I can't sell it.

Indeed, but just because you're not allowed to sell something as a dietary supplement doesn't make it "banned," really. At least not in the blanket way you've implied since the beginning of this.

Other vendors have already been visited/notified since my visit, per the other posts on this board.

Link to this? The only other thread I see is the one wherein RI mentions that "other businesses" have been notified, which no doubt refers to the warning letter to you.


This is my point. It hasn't been outlawed. You just can't sell it as a dietary supplement, because it's not a dietary supplement. If it could be considered a dietary supplement, it's possible that you could change your labeling and fix it. Unfortunately, since you're selling it for human consumption and it's not a dietary supplement/food, the only category left for it is 'drug.'

I'm also curious as to what you're going to do about other substances you currently sell that can't be considered dietary supplements and are not approved drugs. Have you spoken to Mr. Price about this?

And yeah, the RI post has no mention of the FDA; in fact, they explicitly say they're taking action BEFORE the FDA can get involved. So yeah, your use of the word "banned" seems to have scared at least one vendor into preemptively ceasing sales.

#7 Mike M

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Posted 20 September 2010 - 11:41 PM

You guys are impossible. No need for us to go back and forth. I can't sell it anymore so no need in arguing over it.
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#8 Pike

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Posted 21 September 2010 - 12:31 AM

Here's the deal -- there is no such thing as an "unregulated" product that is intended for human or animal ingestion. It is either a drug or it's a food (dietary supplements fall under the umbrella of foods).

In asking before about how much the claims issue contributed to this injunction, I was wondering whether piracetam could be sold "not for human consumption" without violating the relevant acts.


ah! clever, much like how DMSO is sold to body builders as a "solvent."

hmm... but then we would have to figure out some sort of physical property it would have that might warrant it's industrial use?
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#9 FortFun

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Posted 28 September 2010 - 12:31 PM

Mike M: "You guys are impossible. No need for us to go back and forth. I can't sell it anymore so no need in arguing over it."

Yeah, well some of here actually care about nootropics and aren't just worried about whether or not you personally can continue to make a profit!

Seems to me we can place big shady supplement vendors and big pharma in the same bucket, as both exploit for the same purpose....$$Dollars$$ - damn the consequences to the community!

I hate to pick on moderator chronos once again, since he actually seems to finally get what I have been saying from the beginining.

But he did delete another one of my posts that unfortunately was relevant to the discussion. Maybe this time if I leave out the quote from chronos: "Smartpowders/primaforce is fine. I've been using Mike's stuff for years, and he does good business.", he might give more thought to how he edits my posts. Or maybe I receive strike two from him as a moderator???

Point being, my deleted post referenced the following FDA language: "To be a dietary supplement a product must, among other things, "bear[ ] or contain[ ] one or more ... dietary ingredients"

I don't want another debate about whether or not a product becomes a drug because it is not a dietary supplement. We all here are very familar with the label "not for human consumption", no???

My question is the wording from the FDA quote mentioned above. Is Choline xxxx a dietary ingredient? Or, aren't there other 'official' dietary ingredients that could be mixed with piracetam that would then allow the mixed product to be sold as a dietary supplement? I have not looked any deeper than the letter, but it does clearly state that a dietary supplement must contain one or more dietary ingredients! Not every ingredient must be a dietary ingredient (e.g. Piracetam?), just one or more, right? Or wrong?

Personally I think the nootropics community is better off without FDA targeted vendors like mike m / smartpowders doing this. Whether he removes his false labeling claims, places a warning saying ' not for human consumption', or mixes ingredients, I don't think this helps our cause. He has already done enough to jeopardize piracetam supply by labeling it as a dietary supplement even though the FDA told him not to.

My question is to other vendors, or lawyers who may know. Does mixing dietary ingredients with piracetam provide a route to making piracetam available as a dietary supplement (in addition to other options like 'not for human consumption' type labeling for non-drugs/non-supplements or just not labeling of it as a supplement or drug like the warned vendor did)?

Thanks.

(edit - slight verbage change in bold)

Edited by FortFun, 28 September 2010 - 12:43 PM.

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#10 aLurker

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Posted 28 September 2010 - 01:00 PM

I might start to sell piracetam as a filler for pots with plastic flowers. I'm sure you guys wouldn't use it for anything else.
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#11 FortFun

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Posted 28 September 2010 - 01:06 PM

I might start to sell piracetam as a filler for pots with plastic flowers. I'm sure you guys wouldn't use it for anything else.


Grrrrr!!!! I was going to do that!! :)

#12 kismet

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Posted 28 September 2010 - 01:15 PM

@grape,
so to continue selling piracetam it would have to be a. sold as a product "not for human use" or b. someone would have to "successfully challenge[s] FDA's classification of piracetam as beyond the scope of supplements."?
What are the odds for either of those working?

#13 FortFun

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Posted 28 September 2010 - 01:25 PM

@kismet

or c. piracetam mixed with 'official' dietary ingredients

Not sure, but the warning letter seems to make that implication.

really wondering on this one...as an option. Its potentially a floodgate for a lot of nootropics or other things. almost seems too easy.



#14 Deckah

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Posted 28 September 2010 - 05:59 PM

Anyone know of any studies on Piracetam and fish? (ie: fish antibiotics/amoxicillin)

http://www.ncbi.nlm.nih.gov/pubmed/7417117


Fish need healthy minds too.
Posted Image

:laugh:

Edited by Kdvwest, 28 September 2010 - 06:01 PM.

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#15 chrono

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Posted 30 September 2010 - 10:42 AM

Point being, my deleted post referenced the following FDA language: [i]"To be a dietary supplement a product must, among other things, "bear[ ] or contain[ ] one or more ... dietary ingredients"

Not every ingredient must be a dietary ingredient (e.g. Piracetam?), just one or more, right? Or wrong?

Are you asking if unapproved drugs can be sold over the counter if they're simply mixed with an approved supplement? That would be a no.
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#16 Grapevine

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Posted 01 October 2010 - 12:49 AM

Point being, my deleted post referenced the following FDA language: [i]"To be a dietary supplement a product must, among other things, "bear[ ] or contain[ ] one or more ... dietary ingredients"

Not every ingredient must be a dietary ingredient (e.g. Piracetam?), just one or more, right? Or wrong?

Are you asking if unapproved drugs can be sold over the counter if they're simply mixed with an approved supplement? That would be a no.


So that's why I can't find any oxycodone granola?

Edited by Grapevine, 01 October 2010 - 12:50 AM.

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#17 meursault

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Posted 01 October 2010 - 04:24 AM

@grape,
so to continue selling piracetam it would have to be a. sold as a product "not for human use" or b. someone would have to "successfully challenge[s] FDA's classification of piracetam as beyond the scope of supplements."?
What are the odds for either of those working?


All 21 posts by gravepine have been in the retailer/product section.
How about those odds?
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#18 Grapevine

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Posted 01 October 2010 - 04:31 AM

@grape,
so to continue selling piracetam it would have to be a. sold as a product "not for human use" or b. someone would have to "successfully challenge[s] FDA's classification of piracetam as beyond the scope of supplements."?
What are the odds for either of those working?


All 21 posts by gravepine have been in the retailer/product section.
How about those odds?


Hey, I'll be the first one to tell you that I joined this site specifically after being linked to the original thread by Mike talking about the supposed ban from a thread on SomethingAwful. It sounded fishy, and I wanted to make my thoughts heard and learn more. I achieved my goals and have stuck around because I have a mild interest in the subject matter of these forums as a whole, although not enough to really follow any threads other than those regarding the "ban".

Edit: I'd hoped the amount of effort I'd put into getting an answer and my honesty in admitting I was mistaken in some of my accusations-- no, it wasn't just as simple as a labeling issue-- would be enough, but I'll post in some other threads if it would help you feel better about my credibility. :)

Edited by Grapevine, 01 October 2010 - 04:36 AM.


#19 chrono

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Posted 01 October 2010 - 09:56 AM

All 21 posts by gravepine have been in the retailer/product section.
How about those odds?

As this site has a huge number of people who register just to make a few posts on a single issue, I'd say the odds are actually pretty favorable. And since grapevine really isn't saying much aside from trying to make sense of the FDA's position on the matter (and doing a better job than most regulars here), I'm not quite sure what your observation is meant to be in aid of.

#20 e Volution

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Posted 12 October 2010 - 12:39 AM

So guys, where is the best place to get Piracetam now? I see NutraPlanet still have it but they have two brands, their own and PrimaForce. Can anyone comment which is the highest quality/most reliable (+link to another site if its neither of those two)? Cheers...

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#21 chrono

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Posted 12 October 2010 - 02:45 AM

Cerebral Health has it in stock, as well. The subject of piracetam purity has been done to death on this board, and the ridiculous vitriol the topic inevitably churns up means that (unfortunately) we're not going to discuss it in this thread.

@grapevine: did you ever get a chance to ask your lawyer friend about the feasibility of "not for human consumption" sale?

Edited by chrono, 12 October 2010 - 03:34 AM.



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